Nebulizer

ABSTRACT

A nebulizer is proposed which comprises an insertable container and a securing means for holding the container in the nebulizer such that the container can move back and forth but can not be separated. The securing means is formed by a metal unitary part. The securing means forms a transportation lock for holding the container unmovable in the housing in a delivery state of the nebulizer. The securing means forms a cage which encompasses the container.

The present invention relates to a nebulizer for dispensing a fluid.

One starting point for the present invention is a nebulizer illustratedin WO 2006/125577 A2. The nebulizer comprises, as a reservoir for fluidwhich is to be atomized or nebulized, an insertable rigid containerhaving an inner bag containing the fluid and a pressure generator with adrive spring for delivering and atomizing the fluid. Preferably, thecontainer is secured against removal. For the purpose, the nebulizer ofits housing may be designed such that it can not be opened after thecontainer has been inserted.

Preferably, the container is pre-installed in nebulizer in the deliverystate. In particular, the pre-installed container is held by atransportation lock unmovable within the housing in the delivery statein order to avoid any undesired opening of the container.

Before being used for the first time the nebulizer is completely closed.Thus, the preinstalled container is opened by a delivery tube piercing asealing and a septum to fluidically connect to the inner bag of thecontainer. Further, the transportation lock is opened so that thecontainer can move inside the nebulizer back and forth.

By rotating the lower housing part of the nebulizer the drive spring canbe put under tension and fluid can be sucked into a compression chamberof the pressure generator. Simultaneously, the container is moved intothe lower housing part in a stroke movement within the nebulizer andwhen tensioned for the first time the container may be pierced throughits base by a piercing element in the lower housing part to allowventing of the container. After manual operation of a locking elementthe drive spring is released and the fluid in the pressure chamber isput under pressure by the drive spring and is delivered or atomizedthrough a nozzle into a mouthpiece as an aerosol, without the use ofpropellant gas.

WO 2007/022898 A2 discloses a similar nebulizer. A container can beinserted into a housing of the nebulizer. The housing is closed by alower or bottom housing part. The container is moving axially forth andback during conveying of the fluid to be nebulized, during pressuregeneration and/or during nebulization. A counter can be arranged in thehousing part. The counter locks the nebulizer against further use if apredetermined number of operations has been reached or exceeded. Then,the housing part may be replaced together with the counter and thecontainer. The container may be connected inseparably with the housingpart. However, WO 2007/022898 A2 does not describe a simple andinexpensive construction for connecting the container with the housingpart inseparably and such that the container is moveable back and forthwithin the housing during conveying of the fluid, pressure generationand/or nebulization.

Object of the present invention is to provide a nebulizer with optimizedhandling and/or simple assembly or construction, even with pre-installedcontainer.

The above object is achieved by a nebulizer as described herein.Preferred embodiments are also described herein.

The nebulizer comprises a securing means for holding the container inthe housing or a housing part thereof inseparably, wherein the containeris moveable back and forth within the housing during conveying of fluid,pressure generation and/or nebulization. This allows opening of thenebulizer and simultaneously prevents separation of the container fromthe housing or housing part of the nebulizer.

According to a first aspect of the present invention, the securing meanscomprises or consists of a metal and/or stamping part. This allows asimple construction and, in particular, integration of the securingmeans into current designs.

According to a second aspect of the present invention, the securingmeans consists of a single unitary part. This allows a very simple andinexpensive construction.

According to a third aspect of the present invention, the securing meansdoes not only connect the container inseparably with the housing orhousing part such that the container is moveable back and forth withinthe housing during conveying of the fluid, pressure generation and/ornebulization, but also forms in a transportation lock which holds thecontainer unmoveably in the housing in a delivery state, in particularwith the pre-installed container being still closed. This facilitatesassembly and avoids any undesired opening of the container in thedelivery state. Further, the multiple functions of the securing meanssimplify construction.

Additionally or alternatively the securing means may comprise an openingmeans for opening a venting hole of the container. This additionalfunction simplifies the construction as well.

According to a fourth aspect of the present invention, the nebulizer orhousing comprises a cage as securing means for holding the containersuch that the container is moveable back and forth, but is inseparablefrom the housing or a housing part thereof, and/or such that thecontainer is unmoveably held in a delivery state of the nebulizer. Thisallows a simple construction. In particular, the cage is ideal forallowing a limited moveability of the container relative to the housingor housing part and simultaneously connecting the container inseparablywith the housing or housing part. This allows a very simple andinexpensive construction.

Preferably the nebulizer has the still closed container provided thereinand the nebulizer is constructed so that the container is opened insidethe nebulizer before or during the first use of the nebulizer. Thisbasic idea is hereinafter called also “pre-installed container”. Thismakes operation easy as there is no need to open the nebulizer, insertthe container and close the nebulizer. Moreover, undesirable soiling ordamage to the nebulizer caused by incorrect handling when inserting thecontainer can thus be prevented. Accordingly, there is betteroperational safety as it is impossible for the container to be wronglyinserted or otherwise misused during insertion.

The different aspects of the present invention mentioned above anddescribed in the following can be realized independently from each otherand in any combination.

Further advantages, features, characteristics and aspects of the presentinvention will become apparent from the claims and the followingdescription of preferred embodiments with reference to the drawings. Itshows:

FIG. 1 a schematic section of a known nebulizer in a non-tensionedstate;

FIG. 2 a schematic section, rotated through 90° compared with FIG. 1, ofthe known nebulizer in a tensioned state;

FIG. 3 a schematic section of a nebulizer in a delivery state with apartly closed housing and with a pre-installed, closed container;

FIG. 4 a schematic section of the nebulizer according to FIG. 3 in anactivated, tensioned state with the completely closed housing and withthe opened container;

FIG. 5 a schematic section of the nebulizer according to FIG. 4 in anon-tensioned state;

FIG. 6 a schematic section of a nebulizer according to a firstembodiment of the present invention with a partly closed housing andwith a securing means in a housing part holding unmoveably a containerin the nebulizer;

FIG. 7 a perspective view of the securing means;

FIG. 8 a side view of the securing means holding the associatedcontainer unmoveably;

FIG. 9 a schematic partial view of a part of the nebulizer with openedsecuring means so that the container can move;

FIG. 10 a schematic section of a nebulizer according to a secondembodiment of the present invention in a delivery state without lowerhousing part;

FIG. 11 a perspective view of the container of the nebulizer accordingto FIG. 10 with an associated securing means;

FIG. 12 a schematic section of the nebulizer according to FIG. 10 in theactivated, non-tensioned state; and

FIG. 13 a partial enlarged view of FIG. 12.

In the Figures, the same reference numerals have been used for identicalor similar parts, resulting in corresponding or comparable propertiesand advantages, even if the associated description is not repeated.

FIGS. 1 and 2 show a known nebulizer 1 for atomizing a fluid 2,particularly a highly effective pharmaceutical composition or the like,diagrammatically shown in a non-tensioned state (FIG. 1) and in atensioned state (FIG. 2). The nebulizer 1 is constructed in particularas a portable inhaler and preferably operates only mechanical and/orwithout propellant gas.

When the fluid 2, preferably a liquid, more particularly apharmaceutical composition, is nebulized, an aerosol 14 (FIG. 1) isformed, which can be breathed in or inhaled by a user. Usually theinhaling is done at least once a day, more particularly several times aday, preferably at set intervals, depending on the complain or illnessfrom which the patient is suffering.

The nebulizer 1 is provided with or comprises an insertable container 3containing the fluid 2. The container 3 thus forms a reservoir for thefluid 2 which is to be nebulized. Preferably, the container 3 containsan amount of fluid 2 or active substance which is sufficient to provideup to 200 dosage units, for example, i.e. to allow up to 200 sprays orapplications. A typical container 3, as disclosed in WO 96/06011 A1,holds e.g. a volume of about 2 to 10 ml.

The container 3 is substantially cylindrical or cartridge-shaped andonce the nebulizer 1 has been opened the container can be insertedtherein from below and changed if desired. It is preferably of rigidconstruction, the fluid 2 in particular being held in a collapsible bag4 in the container 3.

The nebulizer 1 comprises preferably a pressure generator 5 forconveying and nebulizing the fluid 2, particularly in a preset andoptionally adjustable dosage amount. The pressure generator 5 comprisespreferably a holder 6 for the container 3, an associated drive spring 7,only partly shown, a locking element 8 which can be manually operated torelease the spring 7, a conveying element, such as a conveying tube 9, anon-return valve 10, a pressure chamber 11 and/or an nozzle 12 fornebulizing the fluid 2 into a mouthpiece 13. The container 3 is fixed orheld in the nebulizer 1 via the holder 6 such that the conveying tube 9penetrates into the container 3. The holder 6 may be constructed so thatthe container 3 can be exchanged.

As the drive spring 7 is axially tensioned the holder 6 with thecontainer 3 and the conveying tube 9 is moved downwards in the drawingsand fluid 2 is sucked out of the container 3 into the pressure chamber11 of the pressure generator 5 through the non-return valve 10(conveying of the fluid 2, suction stroke). Then, the nebulizer 1 is inthe so-called activated or tensioned state.

During the subsequent relaxation after actuation of the locking element8 the fluid 2 in the pressure chamber 11 is put under pressure as theconveying tube 9 with its now closed non-return valve 10 is moved backupwards by the relaxation of the drive spring 7 and now acts as apressing ram or piston (pressure generation and/or nebulization). Thispressure forces the fluid 2 through the nozzle 12, whereupon it isnebulized into the aerosol 14, as shown in FIG. 1.

Generally, the nebulizer 1 operates with a spring pressure of 5 to 200MPa, preferably 10 to 100 MPa on the fluid 2, with a volume of fluid 2delivered per stroke of 10 to 50 μl, preferably 10 to 20 p. 1, mostpreferably about 15 μl. The fluid 2 is converted into or nebulized asaerosol 14 the droplets of which have an aerodynamic diameter of up to20 μm, preferably 3 to 10 μm. Preferably, the generated jet spray has anangle of 20° to 160°, preferably 80° to 100°. These values also apply tothe nebulizer 1 according to the teaching of the present invention asparticularly preferred values.

A user (not shown) can inhale the aerosol 14, while an air supply can besucked into the mouthpiece 13 through at least one air supply opening15.

Preferably, the nebulizer 1 can be manually activated or tensioned. Thenebulizer 1 comprises preferably an upper housing part 16 and an innerpart 17 which is rotatable relative thereto (FIG. 2) having an upperpart 17 a and a lower part 17 b (FIG. 1), while an in particularmanually operable (lower) housing part 18 is releasable fixed,particularly fitted onto the inner part 17, preferably by means of aretaining element 19. Preferably, the housing parts 16 and 18 form ahousing of the nebulizer 1. In order to insert and/or replace thecontainer 3 the housing part 18 can be detached from the nebulizer 1 orits housing.

The housing part 18 can be rotated relative to the upper housing part16, carrying with it the part 17 b of the inner part 17. As a result thedrive spring 7 is tensioned in the axial direction by means of a gear ortransmission (not shown) acting on the holder 6. During tensioning thecontainer 3 is moved axially downwards until the container 3 assumes anend position as shown in FIG. 2. In this activated or tensioned statethe drive spring 7 is under tension. During the nebulizing process thecontainer 3 is moved back into its original position (non-tensionedposition or state shown in FIG. 1) by the drive spring 7. Thus thecontainer 3 executes a lifting or stroke movement during the tensioningprocess and during the atomizing process.

The housing part 18 preferably forms a cap-like lower housing part andfits around or over a lower free end portion of the container 3. As thedrive spring 7 is tensioned the container 3 moves with its end portion(further) into the housing part 18 or towards the end face thereof,while an aeration means, such as an axially acting spring 20 arranged inthe housing part 18, comes in contact with base 21 of the container 3and pierces the container 3 or a base seal thereon with a piercingelement 22 when the container 3 makes contact with it for the firsttime, to allow air in or aeration.

The nebulizer 1 may comprise a monitoring device 23 which counts theactuations of the nebulizer 1, preferably by detecting the rotation ofthe inner part 17 relative to the upper part 16 of the housing.Preferably, the monitoring device 23 blocks the actuation or use of thenebulizer 1, e.g. blocks the actuation of the locking element 8, when acertain number of actuations or discharged doses has been reached orexceeded.

A preferred construction and mode of the inhaler or nebulizer 1 will nowbe described in more detail with reference to FIGS. 3 to 5, butemphasizing only essential differences from the nebulizer 1 according toFIGS. 1 and 2. The remarks relating to FIGS. 1 and 2 thus applypreferably accordingly or in a similar manner, while any desiredcombinations of features of the nebulizer 1 according to FIGS. 1 and 2and the nebulizer 1 described below are possible.

FIGS. 3 to 5 show, in schematic sectional views, a nebulizer 1 accordingto a preferred embodiment of the present invention. FIG. 3 shows thenebulizer 1 in a delivery state, i.e. with pre-installed container 3which is still closed. In this state, the housing of the nebulizer 1 isnot completely closed, in particular the housing part 18 is notcompletely pushed on the inner part 17. FIGS. 4 and 5 show the nebulizer1 in an activated and/or tensioned state with the housing completelyclosed and with the container 3 opened. In FIG. 4, the nebulizer 1 ordrive spring 7 is tensioned, i.e. the container 3 is in its lowerposition. FIG. 5 shows the nebulizer 1 in a non-tensioned state, e.g.after the delivery or discharge of one dose of the fluid 2; thecontainer 3 is in its upper position.

The container 3 is already mounted or pre-installed in the nebulizer 1in the delivery state, as shown in FIG. 3. In this state, the container3 is still closed, i.e. there is no fluidic connection between thecontainer 3 or its bag 4 on one hand and the nebulizer 1 or its pressuregenerator 5 or the conveying element on the other hand.

The container 3 comprises a fluid outlet 24 for outputting the fluid 2to be dispensed. In particular, the fluid outlet 24 allows a fluidicconnection between the container 3 or its bag 4 on one hand and thenebulizer 1, its pressure generator 5 or the conveying element on theother hand.

The fluid outlet 24 has an inner closure 25 that is preferably formed bya septum, a membrane, a plastic seal or the like and/or is providedinside the container 3. Optionally, a second or outer closure 26 can beprovided.

Preferably, the closures 25 and 26 are designed such that successiveopening is possible by means of one common element, in particular theconveying element or conveying tube 9 or the like, and/or by piercing.

In the preferred embodiment, the first closure 25 and second closure 26are arranged one after the other and/or spaced in axial direction ordirection of the stroke movement of the container 3 or with respect tothe main outlet direction of the fluid 2.

Generally, the container 3, fluid outlet 24 or closures 25 or 26 areopened in particular by means of a conveying element, such as theconveying tube 9, or the like and/or by piercing or in any othersuitable manner. In particular, the opening is achieved by moving thecontainer 3 relative to the nebulizer 1 or conveying element or tube 9or the like and/or by movement in longitudinal or axial direction.

Preferably, the first or inner closure 25 is formed or supported by aclosure part 27 extending from the outlet or head end of the container 3into the container 3 or bag 4. The second or outer closure 26 ispreferably located adjacent to the head or axial end of the container 3and/or held or connected to a flange 28, which can be formed by theclosure part 27 or any other suitable part. However, otherconstructional solutions are possible.

In the delivery state according to FIG. 3, the container 3 has beenpre-installed, i.e. inserted into the nebulizer 1. However, thecontainer 3 or its fluid outlet 24 is not yet opened. In particular, thesecond closure 26 is already opened, but not the first closure 25. Thisis achieved in particular in that the housing of the nebulizer 1 isclosed only partly, i.e. not completely, in the delivery state,preferably by not completely closing or pushing on the housing part 18in the shown embodiment. Preferably, the housing part 18 is snapped onor inserted only partly in the delivery state.

In particular, the container 3 is attached to or held by or secured inthe housing part 18, in particular by a transportation lock 29, which ispreferably arranged within or at the housing part 18. The transportationlock 29 holds the container 3 preferably temporarily, in particularbefore attaching the housing part 18 to the nebulizer 1 and/or in thedelivery state. In particular, the transportation lock 29 holds thecontainer 3 fixed during the fluidic connection of container 3 and/orduring the mechanic connection of container 3, here with holder 6.Preferably, the transportation lock 29 holds the container 3 fixedduring opening, in particular piercing, the container 3.

In the delivery state, in which the nebulizer 1 can be shipped ordelivered to the user or is still packed, the nebulizer 1 or the housingpart 18 is preferably secured, in particular by means of a securingmember 30, such that the container 3 and/or housing part 18 are heldsufficiently spaced from the nebulizer 1 or upper housing part 16 and/orprevented from being completely inserted or pushed on the conveyingelement or tube 9, the housing or inner housing part 17 or the likeand/or such that (complete) opening of the container 3, namely of thefirst closure 25, is prevented.

In the shown embodiment, the securing member 30 is preferably mountedbetween the housing part 18 and the upper housing part 16 and preferablyengages with or between the housing parts 16 and 18, so that the housingpart or lower part 18 is axially secured or is kept or held sufficientlyaway or spaced from the upper housing part 16 to be able to hold the(still) closed container 3 or first closure 25 away from the conveyingtube 9.

In the preferred embodiment, the securing member 30 is at leastsubstantially hollow and/or cylindrical and is disposed axially betweenthe (lower) housing part 18 and the upper housing part 16. To activatethe nebulizer 1 or prepare its for use, i.e. to push the housing part 18fully on in the axial direction and thereby open the container 3, thesecuring member 30 first has to be removed or released or opened. In theshown preferred embodiment, the securing member 30 is constructed in themanner of a banderole or the like, made of plastics, for example, and/orcan be manually opened, removed or destroyed. The securing member 30 mayalternatively or simultaneously form or constitute a seal of origin.However, other embodiments of the securing member 30 are also possible,e.g. in the form of a security tag or the like.

Preferably, the container 3 and/or housing part 18 are held positivelyor in a form-fit or interlocking manner in the delivery state. This isachieved in the preferred embodiment in particular by means of thetransportation lock 29 acting between the container 3 and the housingpart 18, and the securing member 30 acting between the housing part 18and the housing of the nebulizer 1 or the upper housing part 16 or thelike. However, the transportation lock 29 or securing member 30 couldalso act directly between the container 3 on one hand and the nebulizer1, its housing, the upper housing part 16, the inner housing part 17 orthe holder 6 on the other hand.

In the non-activated position, the housing part 18 is preferably securedso that it cannot be lost and, in particular, cannot be released. Then,the housing or lower part 18 of the nebulizer 1 can no longer bedetached from the nebulizer 1 after it has been (partially) axiallypushed on for the first time, i.e. the nebulizer 1 cannot be opened anylonger, with the result that that the container 3 cannot be changed,i.e. cannot be removed again.

In order to secure the housing part 18, it is preferably held or latchedpositively or in an interlocking or form-fit manner. Preferably, thehousing part 18 is secured by means of at least one latching lug 31,protrusion, nose or the like which engages in an associated latchingrecess 32 in the housing part 18 or the like and, thereby, secures thehousing part 18 against axial removal by interlocking engagement. In thepresent embodiment, the latching lug 31 may be formed by or at alatching arm 33 which can preferably flex. Thus, a ratchet-like meansfor securing the housing part 18 to the nebulizer 1 or its housing orthe upper housing part 16 is formed. However, other constructionalsolutions are also possible.

Once the security member 30 has been removed a user (not shown) can pushthe housing part 18 fully on in the axial direction and thereby open thecontainer 3, i.e. first closure 25, by inserting the conveying elementor conveying tube 9. FIGS. 4 and 5 show this activated state with thehousing part 18 pushed fully on and/or the container 3 open (fluidicallyconnected to the nebulizer 1 or its pressure generator 5 or theconveying element or tube 9). In this pushed on or activated state, thehousing part 18 is preferably secured or axially fixed again byinterlocking engagement, i.e. form-fit manner in axial direction,particularly by the engagement of the latching arm 33 or latching lug 31in a corresponding further latching recess 32 or by means of some othermechanical securing device.

FIG. 4 shows the nebulizer 1 or container 3 in the activated state, thecontainer 3, i.e. first closure 25, is open, i.e. the container 3 or itsfluid 2 is fluidically connected to the nebulizer 1 or its pressuregenerator 5, and the housing part 18 has been pushed fully on in theaxial direction. In order to bring the holder 6 into (complete)engagement with the container 3 at the head end and then be able to movethe container 3 back and/or forth for the suction/tensioning andpressing strokes, it may be necessary to tension the nebulizer 1 or itdrive spring 7 for the first time. During this tensioning process theholder 6 is moved together with the conveying tube 9 axially towards orinto the housing part 18, thus bringing the holder 6 into (complete)engagement with the container 3 and preferably also moving or pressingthe container 3 against the piercing element 22 in the region of thebase of the housing part 18 and thereby piercing or opening a ventinghole 34 in the container base 21. FIG. 4 shows the nebulizer 1 in thistensioned and activated state. The holder 6 is engaged with thecontainer 3 and the conveying tube 9 has been fully inserted into thecontainer 3.

FIG. 5 shows the nebulizer 1 in the relaxed, non-tensioned state, i.e.after atomization or discharge of a dose of the fluid 2. The holder 6and the container 3 are in the upper position. The holder 6 is stillengaged with the container 3 and remains engaged during the further usesof the nebulizer 1. Further, the container 3 is still open andfluidically connected, i.e. the nebulizer 1 remains activated.

The nebulizer 1 is activated after the removal of the securing member 30and (total) axial pushing on of the housing part 18 and can be used inthe same way as the nebulizer 1 shown in FIGS. 1 and 2. Thepre-installation of the container 3 prevents the wrong container 3 orused containers 3 from being inserted in the nebulizer 1 by the user.

As preferably the container 3 cannot then be removed, especially becausethe nebulizer 1 cannot be opened and the housing part 18 cannot beremoved again, undesirable replacement of the container 3 by the userand in particular undesirable interim or subsequent opening of thenebulizer 1 by the user can be prevented.

To prevent unwanted opening of the container 3, particularly of thefirst closure 25, in the delivery state of the nebulizer 1, preferablythe transportation lock 29 is provided. By frictional, forcible orinterlocking engagement, for example, the transportation lock 29prevents the container 3 from undesirably moving axially in thenebulizer 1, e.g. during transportation, in the event of accidentaldropping of the nebulizer 1 or the like.

Preferably, the opening of the transportation lock 29 occursautomatically when closing the nebulizer 1 or its housing completely,i.e. when snapping or pushing on the housing part 18 completely towardsthe upper housing part 16. During this (axial or telescopic) closingmovement, the transportation lock 29 is opened and the container 3released in axial direction preferably only in a last part of themovement and/or just little before the final completely closed positionis reached or just when the final completely closed position is reached.

The closing movement of the nebulizer 1 opens the transportation lock 29preferably automatically. In particular, the transportation lock 29 isopened by the direct or indirect interaction with or actuation by thehousing of the nebulizer 1, the inner part 17 or its lower part 17 b, aholding ring 38 bearing the spring 7 or the like. Preferably, thecontainer 3 and/or first closure 25 are opened as well as thetransportation lock 29 by means of a common actuation, here the closingmovement of the nebulizer 1 or its housing or bottom part 18.

FIGS. 4 and 5 show the transportation lock 29 in the open position, i.e.wherein the container 3 is free to move axially.

Preferably, in the non-activated state, i.e. when the housing part 18has not been pushed on fully, the nebulizer 1 may be locked to preventtensioning of the pressure generator 5, i.e. in particular to preventrotation of the inner part 17 relative to the upper housing part 16.This may be important when the nebulizer 1 is supplied in the deliverystate with the pressure generator 5 not under tension. Accordingly, theinhaler 1 may have a barrier, so that the inner part 17 can only berotated relative to the upper housing part 16 when the housing part 18has been pushed fully on. Alternatively or additionally, the securingmember 30 may block not only pushing on of the bottom part 18 in thedelivery state, but also any rotation of the inner part 17 until thesecuring member 30 has been opened, released or removed.

In the following, a first embodiment of the inhaler or nebulizer 1according to the present invention will be described in detail withreference to FIGS. 6 to 9, wherein only essential differences will beemphasized so that the previous remarks and explications relating to thenebulizers 1 according to FIGS. 1 to 5 apply preferably in acorresponding or similar manner.

FIG. 6 shows in a very schematic, partially sectional view the nebulizer1 according to the first embodiment of the present invention. Thenebulizer 1 is shown a transitional state from the delivery state to theactivated state with not completely closed housing or housing part 18.The housing part 18 has already been pushed on the inner part 17 morethan initially provided in the delivery state such as shown in FIG. 3.Therefore, the container 3 has already been opened in the state shown inFIG. 6. Further, the securing member 30, which preferably secures thehousing part 18 in the delivery state against pushing on the inner part17, has already been released or opened or removed in the state shown inFIG. 6.

The nebulizer 1 or its housing comprises a securing means 35 for holdingthe container 3 such that the container 3 is moveable back and forth forthe conveying of the fluid 2, pressure generation and/or nebulization,but is inseparable from the housing or housing part 18, and/or such thatthe container 3 is unmoveably held in the delivery state of thenebulizer 1.

The securing means 35 is located or arranged preferably at or in thehousing part 18 as shown in FIG. 6.

FIG. 7 shows in a perspective view a preferred embodiment of thesecuring means 35. FIG. 8 shows the securing means 35 connected with thecontainer 3.

Preferably, the securing means 35 comprises or consists of a metaland/or stamping part and/or consists of a single, unitary part as shownin FIG. 7.

Preferably, the securing means 35 is made of steel, in particular springsteel.

Preferably, the securing means 35 is produced from sheet material bycutting, stamping or the like and/or by bending.

Preferably, the securing means 35 or the part forms a cage, inparticular, encompasses the container 3 or an end portion thereof.

Preferably, the securing means 35 comprises holding elements 36 and/orlocking elements 37. The elements 36 and 37 are preferably designed likearms, fingers leaves or the like. In particular, the elements 36, 37 arealternately distributed over a circumference of the container 3 and/orextend at least essentially axially or in the direction of the back andforth movement of the container 3.

Preferably, the elements 36 and 37 are held by or connected with a base38 of the securing means 35.

Preferably, the securing means 35 or base 38 comprises or holds thepiercing element 22 for piercing the container 3, i.e. opening thecontainer base 21 or its venting hole 34 in the activated and tensionedstate, i.e. when the container 3 reaches its lower end position. In theshown embodiment, the piercing element 22 is formed by a respectivebending of a spring portion 39 of the securing means 35 or its base 38.The spring portion 39 can support or facilitate the (complete or final)connection of the container 3 to holder 6.

The securing means 35 or base 38 comprises preferably at least one ormultiple fixing portions 40 for fixing the securing means 35 at or inthe nebulizer 1 or housing or housing part 18. In particular, the fixingportions 40 may fix the securing means 35 when the securing means 35 ispressed into the housing part 18 by cooperating with the side wall ofthe housing part 18. However, it is also possible to overmold thesecuring means 35, its base 38, the fixing portions 40 or the like.Moreover, the securing means 35 could be connected with the housing part18 or the like in any other suitable manner.

Preferably, the securing means 35 does not only prevent the separationof the container 3 from the nebulizer 1, its housing or housing part 18,but also forms the transportation lock 29 for holding the container 3unmovable in the housing in the delivery state of the nebulizer 1. FIGS.6 and 8 shows this state or situation when the container 3 is held(axially) unmovable by the securing means 35, i.e. when thetransportation lock 29 is closed. In this situation, the container 3 orits preferably radially protruding end or edge 41 of the container 3 isheld between the holding element 36 and locking element 37, inparticular between respectively formed or bent ends of the elements 36and 37.

In the shown embodiment, the container end or edge 41 is caught betweenend portions 36 a and 37 a of the elements 36 and 37. The holdingelements 36 grip or extend over the edge 41 and the locking elements 37or its end portions 37 a grip or extend under the edge 41 or containerbase 21 so that the edge 41 and container 3 are securely held preventingany axial movement of the container 3 relative to the securing means 35and relative to the associated housing part 18 in this state, i.e. withlocked securing means 35/transportation lock 29.

The holding element 36 and the locking elements 37 are distributedalternatingly around the container 3 or edge 41.

Preferably, the end portions 36 a of the holding elements 36 end in afirst radial plane and the end portions 37 a of the locking elements 37end in another, second radial plane, wherein the two planes are axiallyoffset to hold the edge 41 in between and/or wherein the second plane islocated axially between the first plane and the lower end position ofthe container 3 or the lower end of the housing part 18 or the piercingelement 22. Additionally or alternatively, the end portions 36 a end onanother radius (outer radius) than the end portions 37 a and/or areaxially spaced therefrom.

The end portions 36 a and/or 37 a are preferably form like claws or thelike and/or extend preferably radially inwardly.

Preferably, the elements 36 and/or 37 can flex with its free endsradially outwardly.

For example, the ends of the end portions 36 a may be inclined such thatthe container 3 may be inserted into or connected with the securingmeans 35 by a respective axial force so that the holding elements 36flex outwardly to allow passing of edge 41. However, the holdingelements 36 can be flexed outwardly also by a suitable tool (not shown)or the like when the container 3 is inserted, in particular with itsedge 41, into the securing means 35.

Preferably, the holding elements 36 prevent separation of the container3 from the securing means 35 and, thus, from the associated housing part18 or the like.

The locking elements 37 or its end portions 37 a can be flexed radiallyoutwardly in order to open the axial holding or transportation lock 29(this will be explained in detail with reference to FIG. 9 in thefollowing). Then, the container 3 can axially move, in particular backand forth and/or with its edge 41 between the first plane and thepiercing element 22 in the present embodiment.

In the present embodiment, the locking elements 37 comprise actuationportions 37 b (preferably formed at the free ends and/or betweenadjacent end portions 37 a). Preferably, the actuation portions 37 bform axial extensions which may be radially offset. The actuationportion 37 b cooperate with an associated control member 42 or multiplecontrol members 42 of the nebulizer 1 such that the locking elements 37are flexed radially outwardly when (completely) closing the housing toopen the transportation lock 29 (here primarily formed by the lockingelements 37 or its end portions 37 a).

FIG. 6 shows schematically the control member 42 axially spaced from theassociated actuation portion 37 b as the housing has not yet been closed(completely).

FIG. 9 shows a lower part of the completely closed nebulizer 1 withopened transportation lock 29, i.e. with radially outwardly flexedlocking elements 37. FIG. 9 shows that the control member 42 has aninclined guiding surface or the like to convert the axial closingmovement into the radial opening movement of the actuation portion 37 band, thus, of the associated locking element 37 to open thetransportation lock 29, in particular when the housing has beencompletely closed or when the housing part 18 has been pushed completelyon the nebulizer 1.

The control member 42 is preferably formed as an axial protrusion. Itcan be formed by or at a ring 43 or any other bearing means of thenebulizer 1 for counter-bearing the drive spring 7 in the inner part 17or by or at any other suitable component if the nebulizer such as theinner part 17.

The control member 42 may be formed like an axial protruding ring orshoulder or ridge which extends along the ring 43.

The control member 42 may additionally secure the holding elements 36against axial opening when the housing is completely closed asschematically shown in FIG. 9. In this case, the control member 42contacts the holding element(s) 36 or its end portions 36 a peripherallyon the outer side to prevent any outward flexing. Then, the securingmeans 35 or its holding elements 36 are secured against opening so thatthe container 3 is securely held within the securing means 35 or thecage formed by the securing means 35 or holding elements 36.

FIG. 9 shows the container 3 in its lower position when the piercingelement 22 can pierce the venting hole 34 or an associated seal attachedto the container base 21.

In the present embodiment, the securing means 35 has multiple functions.It holds the container 3 (in the activated state/with completely closedhousing) such that it can move back and forth, in particular duringconveying of the fluid 2, during pressure generation and/or duringnebulization, wherein the container 3 is inseparable from the housing orthe housing part 18. Further, the securing means 35 forms thetransportation lock 29 and/or holds the container 3 unmovable in thedelivery state of the nebulizer 1. Additionally or alternatively, thesecuring means 35 comprises an opening means, here the piercing element22, for opening the venting hole 34 of the container 3.

Preferably, the securing means 35 forms a cage which cannot be separatedfrom the container 3 after connecting it with the container 3.

The transportation lock 29 and the locking elements 37 are kept openedduring the normal use of the nebulizer 1, in particular as long as thehousing is (completely) closed. When the housing is opened, i.e. thehousing part 18 is detached, the control member 42 may disengage fromthe actuation portions 37 b so that the locking element 37 can close orflex inwardly again. Then, the locking elements 37 may grip with its endportions 37 a over the edge 41 of the container 3 such that anadditional lock is formed which prevents that the container 3 can beseparated from the securing means 35/housing part 18.

The securing means 35 prevents separation of the container 3 from thehousing part 18. Therefore, the container 3 can be replaced or exchangedonly together with the housing part 18 if the housing part 18 can bedetached from the nebulizer 1 or inner part 17 at all. However, it isalso possible that the nebulizer 1 can not be opened. Then, thecontainer 3 can not be replaced.

In the following, a second embodiment of the nebulizer 1 and thesecuring means 35 will be described with reference to FIGS. 10 to 13.The previous remarks and explications apply in a corresponding orsimilar manner. Only essential differences or new aspects of the secondembodiment will be explained.

FIG. 10 shows in a schematic sectional section the nebulizer 1 accordingto the second embodiment in the delivery state. The housing part 18 isomitted.

In the second embodiment, the securing means 35 is arranged or locatedat or within the non-detachable part of the housing of the nebulizer 1,in particular at or in the upper housing part 16 or inner part 17. Inparticular, the securing means 35 is located or mounted at or within thering 43 or any other suitable component preferably at the lower end ofthe inner part 17. In the shown embodiment, the securing means 35 isarranged at least primarily between the ring 43 and the container 3.However, other constructional solutions are possible.

FIG. 11 illustrates in a perspective view the container 3 and theassociated securing means 35 in the delivery state. In the shown secondembodiment, the securing means 35 forms an arrangement of multipleholding elements 36 which are preferably finger-like or leaf-like. Theholding elements 36 are annularly arranged around a circumference of thecontainer 3 and/or connected with a ring portion 44 of the securingmeans 35. In particular, the holding elements 36 are connected with theinner edge of the ring portion 44 and extend axially upwardly, i.e. inthe direction of insertion of the container or into the nebulizer 1. Theholding elements 36 are biased against the container 3 and/or inclinedradially inwardly against the container 3.

The securing means 35 or securing ring formed by the ring portion 44 andthe associated holding elements 36 in the shown embodiment comprisespreferably fixing portions 40 for fixing the securing means 35 orsecuring ring at the nebulizer 1, its housing or inner part 17, inparticular at the ring 43 counter-bearing the drive spring 7. The fixingportions 40 extend preferably in axial direction from the ring portion44 and are angled radially outwardly at its free ends so that a form-fitengagement is possible with ring 43 (ring 43 is axially held between thering portion 44 and the free ends of the fixing portions 40 in thepreferred embodiment). Thus, the securing means 35 or securing ring canbe securely fixed at the ring 43. However, other constructionalsolutions are possible as well.

It has to be noted that the securing means 35 or securing ring comprisesor consists of a metal and/or stamping part and/or a single unitary partas already described with respect to the first embodiment.

The holding elements 36 of the securing means 35 or securing ringcooperate preferably with engagement means formed on or by the container3 such that the container 3 is moveable back and forth but isinseparable from the housing or nebulizer 1, and/or such that thetransportation lock 29 is formed and/or that the container 3 is(axially) unmoveably held in the delivery state of the nebulizer 1.

In the shown embodiment, the container 3 comprises at least one, heretwo radial shoulders, protrusions or corrugations 45 as engagementmeans. The corrugations 45 form preferably ring-like ribs or the like onthe outer periphery of the container 3 and/or are axially spaced, inparticular such that the holding elements 36 can engage in between thecorrugations 45.

The engagement means or corrugations 45 are preferably arranged orformed on the container 3 such that the holding elements 36 engage—inparticular in between the two corrugations 45 as schematically shown inFIGS. 10 and 11—in the delivery state such that the container 3 is heldaxially to avoid complete insertion of the container 3 and/or undesiredopening of the container 3 or its first closure 25.

In particular, the upper corrugation 45 prevents that the container 3can be detached from the nebulizer 1 because the holding elements 36 cannot overcome or move over this corrugation 45. Thus, the securing means35 prevent replacement of the container 3 at all.

In the opposite direction, the lower corrugation 45 forms an obstacle orresistance for the holding elements 36 so that the container 3 issecured against further insertion in the delivery state, i.e. thiscorrugation 45 forms together with the securing means 35 or its holdingelements 36 the transportation lock 29). However, this obstacle orresistance can be overcome, i.e. the transportation lock 29 can beopened, by a sufficiently high force, e.g. by manually closing thehousing or manually inserting the container 3, because the holdingelement 36 can flex radially outwardly so that the lower corrugation 45can pass and the container 3 can be inserted further, i.e. can moveupwardly in FIG. 10.

The corrugations 45 can differ in axial or circumferential location,form, radial extension, inclination, dimension or the like as requiredor desired, in particular to realize a secure holding of the container 3in the delivery state, wherein the force is not too high which has to beovercome when the container 3 is further inserted and opened.

FIG. 12 shows the situation with the fully inserted container 3, i.e.the nebulizer 1 in the activated state (with opened transportation lock29) with completely opened container 3. The container 3 is connectedwith holder 6. The drive spring 7 is not tensioned, i.e. the FIG. 12shows the nebulizer in the non-tensioned state.

FIG. 13 shows a partial enlargement of the FIG. 12 in the area of thesecuring means 35. In this state, the container 3 can move essentiallyfreely relative to the securing means 35 axially back and forth duringthe use of the nebulizer 2. However, the holding elements 36 will engagewith the engagement means, here first with the lower corrugation 45,when it is tried to separate a container 3 from the nebulizer 1. The twocorrugations 45 provide double security against separatation of thecontainer 3 after it has been inserted completely or after the securingmeans 35 or holding elements 36 have passed the lower corrugation 45.

Generally, it should be pointed out that in the proposed nebulizer 1 thecontainer 3 can preferably be inserted, in the nebulizer 1.Consequently, the container 3 is preferably a separate component.However, the container 3 may theoretically be formed directly by thenebulizer 1 or part of the nebulizer 1 or may otherwise be integrated inthe nebulizer 1.

As already mentioned, individual features, aspects and/or principles ofthe embodiments described may also be combined with one another asdesired and may be used particularly in the nebulizer according to FIGS.1 and 5 but also in similar or different nebulizers.

Unlike freestanding equipment or the like the proposed nebulizer 1 ispreferably designed to be portable and in particular is a mobile handoperated device.

The proposed solution may, however, be used not only in the nebulizers 1specifically described here but also in other nebulizers or inhalers,e.g. powder inhalers or so-called metered dose inhalers.

Preferably, the fluid 2 is a liquid, as already mentioned, especially anaqueous pharmaceutical formulation. However, it may also be some otherpharmaceutical formulation, a suspension or the like.

According to an alternative embodiment the fluid 2 may also compriseparticles or powder. In this case, instead of the expulsion nozzle 12,some other kind of supply device may be provided, especially anexpulsion opening (not shown) or a supply channel (not shown) forsupplying the fluid to or powder or the like into the mouthpiece 13. Theoptional air supply opening 15 then serves to supply ambient airpreferably in parallel so as to general or allow an airflow with asufficient volume for breathing in or inhaling through the mouthpiece13.

If necessary the fluid 2 may also be atomized by means of a propellantgas.

Preferred ingredients and/or formulations of the preferably medicinalfluid 2 are listed in particular in WO 2009/047173 A2 which isincorporated herewith by reference. As already stated, these may beaqueous or non-aqueous solutions, mixtures, formulations containingethanol or free from solvent, or the like.

LIST OF REFERENCE NUMERALS

-   1 nebulizer-   2 fluid-   3 container-   4 bag-   5 pressure generator-   6 holder-   7 drive spring-   8 locking element-   9 conveying tube-   10 non-return valve-   11 pressure chamber-   12 nozzle-   13 mouthpiece-   14 aerosol-   15 air supply opening-   16 upper housing part-   17 inner part-   17 a upper part of the inner part-   17 b lower part of the inner part-   18 housing part (lower part)-   19 retaining element-   20 spring-   21 container base-   22 piercing element-   23 monitoring device-   24 fluid outlet-   25 first closure-   26 second closure-   27 closure part-   28 flange-   29 transportation lock-   30 securing member-   31 latching lug-   32 latching recess-   33 latching arm-   34 venting hole-   35 securing means-   36 holding element-   36 a end portion-   37 locking element-   37 a end portion-   37 b actuation portion-   38 base-   39 spring portion-   40 fixing portion-   41 edge-   42 control member-   43 ring-   44 ring portion-   45 corrugation

1. A nebulizer (1) for dispensing a fluid (2) comprising an insertablecontainer (3) containing the fluid (2), wherein the nebulizer (1)comprises a housing and a securing means (35) for holding the container(3) in the housing or a housing part (18) thereof inseparably, whereinthe container (3) is moveable back and forth within the housing duringconveying of the fluid (2), pressure generation and/or nebulization,characterized in that the securing means (35) comprises a metal and/orstamping part and/or a single, unitary part.
 2. The nebulizer accordingto claim 1, characterized in that the part forms a cage or ringarrangement.
 3. The nebulizer (1) according to claim 1 for a fluid (2)comprising an insertable container (3) containing the fluid (2), whereinthe nebulizer (1) comprises a housing and a securing means (35) forholding the container (3) in the housing or a housing part (18) thereofinseparably, wherein the container (3) is moveable back and forth withinthe housing during conveying of the fluid (2), pressure generationand/or nebulization, characterized in that the securing means (35) formsa transportation lock (29) for holding the container (3) unmovable inthe housing in a delivery state of the nebulizer (1), wherein thetransportation lock (29) is openable so that the container (3) ismoveable within the housing back and forth.
 4. The nebulizer accordingto claim 3, characterized in that the securing means (35) comprises acage.
 5. The nebulizer according to claim 4 (1) for a fluid (2)comprising an insertable container (3) containing the fluid (2), whereinthe nebulizer (1) comprises a housing for receiving the container (3),wherein the container (3) is moveable back and forth within the housingduring conveying of the fluid (2), pressure generation and/ornebulization, characterized in that the housing comprises a cage as asecuring means (35) for holding the container (3) such that thecontainer (3) is moveable back and forth but is inseparable from thehousing or a housing part (18) thereof and/or such that the container(3) is unmoveably held in a delivery state of the nebulizer (1).
 6. Thenebulizer according to claim 2, characterized in that the cageencompasses an end or bottom portion of the container (3).
 7. Thenebulizer according to claim 1, characterized in that the securing means(35) comprises holding and/or locking elements (36, 37), preferablywherein the holding and/or locking elements (36, 37) are like fingers,arms or claws and/or extend at least axially or in the direction of themovement of the container (3) and/or can be flexed radially.
 8. Thenebulizer according to claim 7, characterized in that locking elements(37) securing the container (3) in a delivery state are actuatable orflexible preferably outwardly by the housing or any other component ofthe nebulizer (1).
 9. The nebulizer according to claim 1, characterizedin that the securing means (35) comprises an opening means for opening aventing hole (34) of the container (3).
 10. The nebulizer according toclaim 1, characterized in that the container (3) is still closed in adelivery state of the nebulizer (1), but already disposed in thenebulizer (1) in the delivery state, the nebulizer (1) being constructedso that the fluid outlet (24) is opened inside the nebulizer (1) beforeor during first use of the nebulizer (1).
 11. The nebulizer according toclaim 1, characterized in that the housing is closed only partly in thedelivery state and completely closed before or for using the nebulizer(1).
 12. The nebulizer according to claim 3, characterized in that thetransportation lock (29) is opened automatically when completely closingthe housing.
 13. The nebulizer according to claim 12, characterized inthat the housing part (18) is snapped on or inserted partly in thedelivery state and which is snapped on or inserted completely forcompletely closing the housing.
 14. The nebulizer according to claim 1,characterized in that the housing part (18) can be replaced togetherwith the container (3), wherein the container (3) is inseparable fromthe housing part (18).
 15. The nebulizer according to claim 1,characterized in that the securing means (35) is located in the housingpart (18).
 16. The nebulizer according to claim 1, characterized in thatthe container (3) is inseparable from the nebulizer (1) or its housing,in particular due to a structure, such as a corrugation (45) or anyother form of the container (3).
 17. The nebulizer according to claim 1,characterized in that the nebulizer (1) is constructed as an inhaler,particularly for dispensing medical aerosol treatment.